Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
Study NCT ID:
NCT03491332
Status:
UNKNOWN
Last Update Posted:
2019-03-18
First Post:
2018-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Heated Breathing Circuit on Intraoperative Core Temperature and Systemic Inflammation After Brain Surgery: a Prospective Randomized Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 117}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-14', 'studyFirstSubmitDate': '2018-03-08', 'studyFirstSubmitQcDate': '2018-04-05', 'lastUpdatePostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'core temperature', 'timeFrame': 'every 30 minute after induction of anesthesia until the end of anesthesia'}, {'measure': 'upper airway temperature', 'timeFrame': 'every 30 minute after induction of anesthesia until the end of anesthesia'}, {'measure': 'upper airway humidity', 'timeFrame': 'every 30 minute after induction of anesthesia until the end of anesthesia'}], 'secondaryOutcomes': [{'measure': 'cytokine level', 'timeFrame': '1, 30, 60, 90, 120, 150, 180, 210, 240 minute after induction and 1 second after the operation', 'description': 'pg/ml for Cytokine level(TNF-a, IL-1, IL-6, IL-8, IL-10)'}, {'measure': 'dead space', 'timeFrame': 'every 30 minute after induction of anesthesia until the end of anesthesia', 'description': '% for Deadspace(Vd/Vt)'}, {'measure': 'intrapulmonary shunt', 'timeFrame': 'every 30 minute after induction of anesthesia until the end of anesthesia', 'description': 'Qs/Qt,'}, {'measure': 'respiratory variables', 'timeFrame': 'every 30 minute after induction of anesthesia until the end of anesthesia', 'description': 'mmHg for respiratory variables(PaO2, PaCO2, PvO2, PvCO2)'}, {'measure': 'compliance', 'timeFrame': 'every 30 minute after induction of anesthesia until the end of anesthesia', 'description': 'L/cmH2O for compliance(△V/△P)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patients Scheduled for Brain Surgery']}, 'descriptionModule': {'briefSummary': 'Mechanical respiration during general anesthesia causes cold and dry gases to reach the lower airway, reduce the function of the airway mucosa, and cause accumulation of secretions. Inhaled dry gas is one of the causes of hypothermia during general anesthesia. To overcome this, the warm-humidifying breathing circuit uses warm, moisture-preserving gas to promote mucus mobility of the airway mucosal ciliate cells and prevents cold gases from evaporating from the mucosal surfaces which results lowering body temperature. We aimed to investigate the effect of newly developed Sohum warm humidifying respiration circuit (SH501) on the prevention of core body temperature reduction during surgery and systemic inflammation reaction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age ≥ 19\n2. scheduled for brain surgery\n\nExclusion Criteria:\n\n1. age \\< 19\n2. patients with severe obstructive lung disease and/or restrictive lung disease patients\n3. patients with infectious disease\n4. surgery with prone position or lateral position\n5. arrhythmia'}, 'identificationModule': {'nctId': 'NCT03491332', 'briefTitle': 'Effect of Heated Breathing Circuit on Intraoperative Core Temperature and Systemic Inflammation After Brain Surgery: a Prospective Randomized Study', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Effect of Heated Breathing Circuit on Intraoperative Core Temperature and Systemic Inflammation After Brain Surgery: a Prospective Randomized Study', 'orgStudyIdInfo': {'id': '1-2017-0087'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'group C', 'description': 'general circuit group', 'interventionNames': ['Device: conventional circuit']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group H', 'description': 'warm circuit group', 'interventionNames': ['Device: conventional humidification circuit']}, {'type': 'EXPERIMENTAL', 'label': 'group SH', 'description': 'new warm circuit group', 'interventionNames': ['Device: new humidifaction heat circuit']}], 'interventions': [{'name': 'conventional circuit', 'type': 'DEVICE', 'otherNames': ['group C for control group (n=39)'], 'description': 'The patient enters the operating room without any pretreatment and attaches a standard patient monitoring device. Anesthesia was performed by intravenous anesthesia. After induction of anesthesia, alveolar recruitment is performed in supine position in all groups with 30 cmH2O for 5 seconds. Mechanical ventilator was set with tidal volume of 8 ml / kg, the inspiratory/ expiratory ratio of 1: 2 and respiratory rate was adjusted for targeting EtCO2 around 35mmHg. Keep the fresh air flow of the ventilator at 3 L / min and set the temperature to 37 ° C for the heating circuits of group H and group SH. An arterial cannulation and subclavian jugular vein catheter is inserted.\n\nThe circuits were applied to each group as follows; conventional circuit or group C, conventional humidification circuit for group H and new humidification heat circuit for group SH, respectively. All other conditions were same among three groups.', 'armGroupLabels': ['group C']}, {'name': 'conventional humidification circuit', 'type': 'DEVICE', 'otherNames': ['group H for conventional humidification circuit (n = 39)'], 'description': 'The patient enters the operating room without any pretreatment and attaches a standard patient monitoring device. Anesthesia was performed by intravenous anesthesia. After induction of anesthesia, alveolar recruitment is performed in supine position in all groups with 30 cmH2O for 5 seconds. Mechanical ventilator was set with tidal volume of 8 ml / kg, the inspiratory/ expiratory ratio of 1: 2 and respiratory rate was adjusted for targeting EtCO2 around 35mmHg. Keep the fresh air flow of the ventilator at 3 L / min and set the temperature to 37 ° C for the heating circuits of group H and group SH. An arterial cannulation and subclavian jugular vein catheter is inserted.\n\nThe circuits were applied to each group as follows; conventional circuit or group C, conventional humidification circuit for group H and new humidification heat circuit for group SH, respectively. All other conditions were same among three groups.', 'armGroupLabels': ['group H']}, {'name': 'new humidifaction heat circuit', 'type': 'DEVICE', 'otherNames': ['group SH for new humidifaction heat circuit (n=39)'], 'description': 'The patient enters the operating room without any pretreatment and attaches a standard patient monitoring device. Anesthesia was performed by intravenous anesthesia. After induction of anesthesia, alveolar recruitment is performed in supine position in all groups with 30 cmH2O for 5 seconds. Mechanical ventilator was set with tidal volume of 8 ml / kg, the inspiratory/ expiratory ratio of 1: 2 and respiratory rate was adjusted for targeting EtCO2 around 35mmHg. Keep the fresh air flow of the ventilator at 3 L / min and set the temperature to 37 ° C for the heating circuits of group H and group SH. An arterial cannulation and subclavian jugular vein catheter is inserted.\n\nThe circuits were applied to each group as follows; conventional circuit or group C, conventional humidification circuit for group H and new humidification heat circuit for group SH, respectively. All other conditions were same among three groups.', 'armGroupLabels': ['group SH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yong Seon Choi, MD, Ph.D', 'role': 'CONTACT', 'email': 'yschoi@yush.ac', 'phone': '+82-2-2227-4966'}], 'facility': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Yong Seon Choi, MD', 'role': 'CONTACT', 'email': 'yschoi@yuhs.ac', 'phone': '+82-2-2228-2428'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}